QA & RA Affairs Manager
- Posted: over a month ago
DTE Oregon QA & RA Affairs Manager Job Posting
Forest Dental Equipment is accepting applications for a Quality and Regulatory Affairs Manager to be responsible for the maintenance of the Quality System compliant to the ISO 13485 standard for Class I and IIa Devices and FDA medical device requirements. This position is also responsible for keeping abreast of any regulatory requirements or changes applicable to the product in worldwide target markets and communicating these requirements to Executive Leaders
Essential Duties & Responsibilities:
- Subject matter expert in Quality and Regulatory compliance, contributing to attaining and maintaining the required registrations/certifications to sell product
- Manage and oversee the Quality Management System; ensuring the best and most current practices are leveraged.
- Establishment and use of metrics to monitor the suitability and effectiveness of the
- Develop, maintain and follows ISO procedures and GMP requirements pertaining to medical devices.
- Responsible for managing the RMA, QC Inspection, Acceptance Activities, Calibration Process, Quality Management System (QMS) TrainingProcess, Material Review Board, and Quality Engineering
- Advise personnel and project teams on quality system and regulatory requirements, coordinates and presents regulatory information, and negotiates with and influences management and colleagues to ensure requirements are
- Ensures that company and quality system are compliant with a ll federal, state, local and company specific regulations as they apply to medical devices or a medical device facility; responsible for ensuring that internal and external audits are performed per current regulatory guidelines/procedures.
- Manage the Internal Audit, CAPA program and Supplier CAPA
- Work with process owners of CAPAs and internal audit findings and ensure appropriate corrective actions plans are implemented and verified for
- Provide oversight to the on-going maintenance of the Quality System procedures; ensure that changes to the procedures are consistent with the intended structure of the Quality
- Minimum of a 4-year degree from an accredited
- ASQ CQA and/or CQE
- Strong knowledge of ISO/FDA regulations and procedures for medical
- Familiar with the FDA510(k)submission process, ISO 13485 standard and CE marking
- Familiar with FDA Establishment Registration, FDA Device Listings, FDA Certificates to Foreign Government.
- Familiar with technical details of medical devices concepts, practices, and
- Proficiency with Microsoft Office and Adobe
- Ability to read, analyze, and interpret standards and
- Ability to manage critical projects to deadlines as part of an interdisciplinary
- Strong interpersonal, oral and written communication skills with the ability to effectively communicate with all levels of the organization, customers and
- Presentation skills, technical writing and editing
- Strong attention to detail and excellent organizational
- Ability and willingness to work flexible/extended hours and light travel may be needed to support the business.
We are an Equal Opportunity Employer, including disability and veteran status.
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- Email: email@example.com
- Phone: 888-633-9269
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AddressBay Minette, AL
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